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Completed

NCT Number: NCT01082367

Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

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Key information

Conditions

Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

3 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of cystic fibrosis
  • Early lower respiratory tract infection with P. aeruginosa,

Exclusion criteria

  • Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
  • Administration of loop diuretics within 7 days prior to study drug administration.
  • Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

TOBI

Drug

TOBI (tobramycin inhaled solution)

Placebo

Drug

Placebo

Primary outcomes

  1. Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle

    Time frame: Day 29

    Sputum/throat swab cultures were assessed.

Secondary outcomes

  1. Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle

    Time frame: Day 91

    Sputum/throat swab cultures were assessed.

  2. Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period

    Time frame: Day 91

    Sputum/throat swab cultures were assessed.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years

Acronym: EARLY

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 8, 2010
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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